CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting ID
Anticipated Duration (Months)
Patients Per Site
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
240 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319
Actual Study Start Date :
May 2, 2019
Anticipated Primary Completion Date :
Apr 21, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Experimental: sacubitril/valsartan

single arm, open label sacubitril/valsartan

Drug: sacubitril/valsartan
Target dose 3.1 mg/kg bid Formulations: Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)
Other Names:
  • LCZ696
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [to end of study, up to 3 years]

      Safety. Assessments include: Adverse Events (AEs)

    2. Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability [to end of study, up to 3 years]

      Safety. Assessments include: Serious Adverse Events (SAEs)

    Eligibility Criteria


    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Signed informed consent

    • On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue

    Exclusion Criteria:
    • Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2

    • Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour washout before baseline visit)

    • History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan

    • Renal vascular hypertension (including renal artery stenosis)

    • Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder

    • History of angioedema

    • Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures

    • Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study

    • Other protocol defined inclusion/exclusion criteria may apply

    Contacts and Locations


    SiteCityStateCountryPostal Code
    1Novartis Investigative SiteLoma LindaCaliforniaUnited States92354
    2Novartis Investigative SiteLos AngelesCaliforniaUnited States90095
    3Novartis Investigative SitePalo AltoCaliforniaUnited States94304
    4Novartis Investigative SiteHollywoodFloridaUnited States33021
    5Novartis Investigative SiteSaint PetersburgFloridaUnited States33701
    6Novartis Investigative SiteAtlantaGeorgiaUnited States30322
    7Novartis Investigative SiteIndianapolisIndianaUnited States46202
    8Novartis Investigative SiteBostonMassachusettsUnited States02115
    9Novartis Investigative SiteAnn ArborMichiganUnited States48109-5238
    10Novartis Investigative SiteMinneapolisMinnesotaUnited States55455
    11Novartis Investigative SiteRochesterMinnesotaUnited States55905
    12Novartis Investigative SiteSaint LouisMissouriUnited States63110
    13Novartis Investigative SiteNew YorkNew YorkUnited States10032
    14Novartis Investigative SiteCharlotteNorth CarolinaUnited States28203
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    46Novartis Investigative SiteToyama-cityToyamaJapan930-0194
    47Novartis Investigative SiteYangsan SiGyeongsangnam DoKorea, Republic of50612
    48Novartis Investigative SiteSeoulKorea, Republic of03080
    49Novartis Investigative SiteSeoulKorea, Republic of03722
    50Novartis Investigative SiteSeoulKorea, Republic of06351
    51Novartis Investigative SiteAshrafiehLebanon166830
    52Novartis Investigative SiteBeirutLebanon
    53Novartis Investigative SiteWarszawaPoland04 730
    54Novartis Investigative SiteWroclawPoland51-124
    55Novartis Investigative SiteCarnaxideLisboaPortugal2799 523
    56Novartis Investigative SiteCoimbraPortugal3000 075
    57Novartis Investigative SiteLisboaPortugal1169 024
    58Novartis Investigative SiteMoscowRussian Federation125412
    59Novartis Investigative SiteSaint PetersburgRussian Federation197341
    60Novartis Investigative SiteSingaporeSingapore119260
    61Novartis Investigative SiteSingaporeSingapore229899
    62Novartis Investigative SiteSowetoGautengSouth Africa2013
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    67Novartis Investigative SiteLausanneSwitzerland1011
    68Novartis Investigative SiteTainanTaiwan70403
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    Sponsors and Collaborators

    • Novartis Pharmaceuticals


    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Novartis Pharmaceuticals Identifier:
    Other Study ID Numbers:
    • CLCZ696B2319E1
    First Posted:
    Dec 24, 2018
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021